On August 19, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-16 (Advisory Opinion) in which it declined to impose sanctions for an arrangement under which the requestor provides gift cards to patients for completing an online learning program related to surgeries. The OIG concluded that although the arrangement would constitute prohibited remuneration under the federal anti-kickback statute (AKS) and the beneficiary inducement prohibitions of the Civil Monetary Penalties Law (CMP), it is unlikely to impact competition among providers or influence selection of a particular provider and therefore determined that the arrangement did not warrant the imposition of sanctions.Continue Reading Advisory Opinion 22-16: OIG Declines to Impose Sanctions for Arrangement Involving Provision of Gift Cards to Patients for Completing Learning Program

The Centers for Medicare and Medicaid Services (CMS) announced a final rule, to be published on May 23, 2019, amending the Medicare Advantage program (Part C) and Prescription Drug Benefit program (Part D) regulations. According to CMS, the purpose of the rule is to lower drug prices and reduce out-of-pocket expenses in the Medicare

The Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule to amend Medicare Advantage (MA) regulations and Prescription Drug Benefit program (Part D) regulations.  The Proposed Rule was published on November 30, 2018. The Proposed Rule is intended to help lower drug prices for health and drug plans and reduce out-of-pocket costs for MA and Part D enrollees. Major provisions include: Providing Plans with increased flexibility in managing drug formularies. Current policy requires Part D formularies to include all drugs in the following categories: (1) antidepressants; (2) antipsychotics; (3) anticonvulsants; (4) immunosuppressants for treatment of transplant rejection; (5) antiretrovirals; and (6) antineoplastics; except in limited circumstances. The Proposed Rule includes three exceptions, allowing: (1) broader use of prior authorization and step therapy; (2) exclusion of drugs that are only a new formulation of an existing single-source drug or biological product, regardless of whether the older formulation remains on the market; and (3) exclusion of drugs with a price increase beyond an inflation-based threshold relative to a baseline month and year.
Continue Reading CMS Proposes Revised Prescription Drug Regulations to Lower Drug Prices and Reduce Out of Pocket Expenses

On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule, updating Medicare Advantage (MA) and the prescription drug benefit program (Part D).  The Final Rule includes, among other provisions:

  • Preclusion List Requirements for Prescribers in Part D and Individuals and Entities in Medicare Advantage, Cost Plans, and PACE: The Final Rule eliminates the MA and Part D prescriber and provider enrollment requirement.  Instead, CMS is compiling a “Preclusion List” of prescribers, individuals, and entities that: (1) are currently revoked from Medicare, under an active reenrollment bar, or have engaged in behavior for which CMS could have revoked enrollment in Medicare and (2) in addition, CMS determines their underlying conduct to be detrimental to the best interests of the Medicare program. The Preclusion List will be made available to MA plans and Part D prescription drug plans, which must deny payment for claims submitted by, or associated with prescriptions written by prescribers and providers on the list.
  • Eliminating “Meaningful Difference” Requirements: Beginning with CY 2019 bid submissions, CMS has eliminated the requirement that MA plans offered by the same organization in the same county comply with the “meaningful difference” requirements, which limit the variety of plans an MA organization can offer in the same county. The Final Rule eliminates the “meaningful difference” requirement for PDP Enhanced Alternative (EA) benefit designs offered by the same organization in the same region, but does not change this requirement between PDP Basic and EA prescription drug plan offerings.
  • Medicare Advantage Uniformity Requirements Flexibility: As an option for all MA plans, the Final Rule allows the plans to reduce cost sharing for certain covered benefits, offer specific tailored supplemental benefits, and offer different deductibles for beneficiaries that meet specific medical criteria.

Continue Reading CMS Updates Medicare Advantage and Part D (Prescription Drug Benefit)

On December 11, 2017, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting a proposed pilot Program involving a collaboration between a pharmaceutical manufacturer (the Requestor), a trade association (Association), a Medicare Advantage Part D plan (MA Plan), a Hospital System, and a Vendor.  As proposed, the program would provide new technology to allow real-time access to patient discharge information for use by MA Plan pharmacists who conduct medication therapy management (MTM) services. 
Continue Reading OIG Advisory Opinion Allows Pilot Collaborative Program Proposed by Pharmaceutical Manufacturer for Medication Therapy Management Interventions

On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule establishing new Anti-Kickback Statute (AKS) safe harbor protections and codifying regulatory exceptions to the Civil Monetary Penalties Law (CMP).

Local Transportation Safe Harbor

This safe harbor protects local transportation made available by an “Eligible Entity” as long as the following conditions are met.  An “Eligible Entity” is any individual or entity, except for individuals or entities (or family members or others acting on their behalf) that primarily supply health care items (for example, durable medical equipment suppliers or pharmaceutical manufacturers).
Continue Reading New Anti-Kickback Safe Harbors and Exceptions to CMP Law